Systems And Methods For Identifying And Locating An Implanted Device

ABSTRACT

A system for identifying an attribute of an implanted medical device, such as an access port. In one embodiment, the identification system comprises a marker included with the implanted medical device, the marker relating to an attribute of the implanted medical device. An external detection device is also included, comprising a signal source that emits an incident electromagnetic signal for impingement on the marker of the implanted medical device, a detector that detects a return signal from the marker resulting from impingement of the incident electromagnetic signal, and a user interface for conveying information relating to the attribute based on detection of the return signal. In the case of an implantable access port, for instance, the described system enables information, such as the ability of the port to withstand power injection of fluids therethrough, to be ascertained even after the port has been subcutaneously implanted within the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/887,675, filed Feb. 2, 2018, now U.S. Pat. No. 10,471,205, which is acontinuation of U.S. patent application Ser. No. 13/101,968, filed May5, 2011, now U.S. Pat. No. 9,884,150, which claims the benefit of U.S.Provisional Application No. 61/331,779, filed May 5, 2010, and titled“Systems and Methods for Identifying and Accessing an Implanted Device,”each of which is incorporated by reference in its entirety into thisapplication.

BRIEF SUMMARY

Briefly summarized, embodiments of the present invention are directed toa system for identifying an attribute of an implanted medical device,such as an access port. Information about the device, such as type,size, location, power injectability, etc. can be ascertained, thusincreasing device success, user convenience, and patient safety.

In one embodiment, the identification system comprises a marker includedwith the implanted medical device, wherein the marker relates to anattribute of the implanted medical device. An external detection deviceis also included for externally detecting the implanted device. Thedetection device includes a signal source that emits an incidentelectromagnetic signal for impingement on the marker of the implantedmedical device, a detector that detects a return signal from the markerresulting from impingement of the incident electromagnetic signal, and auser interface for conveying information relating to the attribute basedon detection of the return signal. In the case of an implantable accessport, for instance, the described system enables information, such asthe ability of the port to withstand power injection of fluidstherethrough, to be ascertained after the port has been subcutaneouslyimplanted within the patient.

These and other features of embodiments of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of embodiments of theinvention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description of the present disclosure will be renderedby reference to specific embodiments thereof that are illustrated in theappended drawings. It is appreciated that these drawings depict onlytypical embodiments of the invention and are therefore not to beconsidered limiting of its scope. Example embodiments of the inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 is a perspective view of an access port and catheter including aplurality of markers, according to one embodiment;

FIG. 2 is a partial cross sectional side view of an implanted accessport and identification system according to one embodiment;

FIG. 3A is a top view of an access port including a plurality of markersaccording to one embodiment;

FIG. 3B is a side view of the access port of FIG. 3A;

FIG. 4A is a partial cross sectional perspective view of an implantedaccess port and identification system according to one embodiment;

FIG. 4B is a side view of a display portion of the identification deviceshown in FIG. 4A;

FIG. 5 is a perspective view of an identification device including alight shield according to one embodiment;

FIG. 6 is a perspective view of the light shield of FIG. 5;

FIG. 7 is a perspective view of an identification device according toone embodiment;

FIG. 8 is a perspective view of an identification device according toone embodiment;

FIGS. 9A and 9B are various views of an access port and representativeimages as depicted by the identification device according to oneembodiment;

FIGS. 10A-10C show various examples of markers for an access portaccording to one embodiment;

FIG. 11 is a partial cross sectional perspective view of an implantedaccess port and identification system according to one embodiment;

FIGS. 12A-12C show various views of a needle guide and dressingaccording to one embodiment; and

FIG. 13 is a perspective view of a needle guide and dressing accordingto one embodiment.

DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

Reference will now be made to figures wherein like structures will beprovided with like reference designations. It is understood that thedrawings are diagrammatic and schematic representations of exemplaryembodiments of the present invention, and are neither limiting nornecessarily drawn to scale.

For clarity it is to be understood that the word “proximal” refers to adirection relatively closer to a clinician using the device to bedescribed herein, while the word “distal” refers to a directionrelatively further from the clinician. For example, the end of acatheter placed within the body of a patient is considered a distal endof the catheter, while the catheter end remaining outside the body is aproximal end of the catheter. Also, the words “including,” “has,” and“having,” as used herein, including the claims, shall have the samemeaning as the word “comprising.”

Embodiments of the present invention are generally directed to a systemfor identifying and/or locating an implanted medical device, such as anaccess port, and for facilitating access to such a device. Inparticular, identification of an attribute of the medical device afterimplantation enables a clinician to better utilize the device, thusincreasing device success, user convenience, and patient safety. Inaddition, and as mentioned, the system can assist in locating andaccessing the implanted device, such accessing an access port with aneedle, for instance.

It is appreciated that, though use of the systems and componentsdescribed herein focuses on identification of and access to an implantedaccess port, other types of implanted devices, including medicaldevices, can benefit from the principles and embodiments describedherein.

Reference is first made to FIGS. 1 and 2, which depict various detailsof an implantable access port 20 and a related system, generallydesignated at 10, for identifying and/or characterizing the access portor other implanted medical device, according to one embodiment. Asshown, the access port 20 includes a body 14 defining a fluid cavitythat is covered by a septum 16. A stem 18 extends from the port body 14and serves as an outlet for the fluid cavity. As shown in FIG. 2, thestem 18 is configured to operably connect to a catheter 20 so as toprovide fluid communication between the catheter and the port fluidcavity. Note that the catheter 20 is merely representative of a widevariety of catheters, including PICCs, central catheters, etc., whichcan be employed. Also, though described herein primarily as an accessport, the medical device of the embodiments discussed herein canoptionally include any number of devices subcutaneously implantable intoa body of a patient. The embodiments to be described should thereforenot be so limited.

In accordance with one embodiment, one or more markers 24 are includedon a portion of the catheter 20 as part of the identification system 10.Each marker 24 is configured so as to be visible when imaged by anultrasound device after implantation of the access port 12 under theskin 28 of the patient (FIG. 2). As shown in FIGS. 1 and 2, the markers24 can be arranged in a specified pattern, such as a “barcode” format,that can provide information regarding one or more attributes of theaccess port to which the catheter 20 is operably connected, as in FIG.2. For instance, the markers 24 can relate in one embodiment to theability of the access port to withstand a relatively high fluid flowrate therethrough, also referred to herein as “power injection.” In oneembodiment, for instance, power injection fluid flow rates include aflow of about 5 ml per second at a pressure of about 300 p.s.i., thoughother flow rates and pressures are also possible. In addition, otherattributes of the access port and/or catheter or other medical devicecan also be indicated by the markers 24, including port size, type,fluid cavity capacity, date of implantation, etc.

In one embodiment, the markers 24 include a material that varies indensity and/or surface reflectivity from the catheter material so as toprovide an ultrasonically detectable specimen. In another embodiment,the markers 24 include an ultrasonically opaque, non-metallic andMM-compatible dye included in a translucent catheter, such as by coatingthe catheter, extruding it into the catheter, etc.

In another embodiment, it is appreciated that the markers can beconfigured to be imaged or detected via another modality that issufficiently transmissive through body tissue including optical, RF,fluorescence (such as via UV or IR-wavelength electromagneticradiation), magnetic, etc. In one embodiment, for example, the markerscan include a dark material such as tungsten, to provide a highdark/light contract between the markers and the catheter, port, etc.,such that the contrast is detected when illuminated by a suitable lightsource and optically imaged by a camera. Also, the markers in oneembodiment can be included on the body of the access port itself.

The system 10 further includes a detection device, or externalidentification (“ID”) device 30, configured to detect the markers 24 ofthe implanted catheter 20 (or, optionally, the port 12) when the deviceis brought into sufficient proximity to the subcutaneous markers 24while remaining external to the patient's body, such as by placing theID device against the patient's skin 28. In the present embodiment theID device 30 includes an ultrasound imaging device. As such, the IDdevice 30 includes an imaging head 34 housing a transducer for emittingultrasound signals and detecting reflected signals. Note that themarkers 24 in one embodiment are sufficiently spaced apart from oneanother to enable the transducer to discern each of the markersaccording to the resolution of the transducer.

In particular, the ultrasound signal emitted by the transducer of theimaging head 34 is configured to travel through the patient's bodytissue and impinge on the markers 24 of the catheter 20. The ultrasoundsignal is then reflected and, as a return signal, is detected uponreceipt by the transducer. The ID device 30 includes the circuitry andalgorithms to enable the return signal to be processed and forinformation relating to detection of the markers 40 to be conveyed to auser via a user interface, such as a display 36 included on the IDdevice.

For instance, in the embodiment shown in FIG. 2, the display 36 includesan image 36A including a message, “power injectable,” to indicate thatthe access port to which the catheter 20 including the markers 24 isconnected is capable of withstanding the pressures and fluid flow ratesassociated with power injection. In the case of the markers 40 forming adetectable pattern, barcode, etc., the ID device circuitry andalgorithms can include functionality to enable the detected pattern tobe interpreted so as to enable identification of the attribute indicatedby the markers 24 to be conveyed to the user of the ID device 30 via theuser interface. In another embodiment, the ID device merely conveys thepresence, number, shape, or other configuration of the markersthemselves so that a user can interpret the markers and determine theattribute represented thereby.

It is appreciated that other messages and/or identifying information canbe depicted on the display 36 relating to the attribute of the accessport or other implanted medical device about which the one or moremarkers 24 are concerned. In other embodiments, it is also appreciatedthat other user interface modalities can be employed, including audioelements, lights, etc., to convey to a user of the ID device informationrelating to the detected markers. One or more control buttons 38 orother control interfaces are included to control functionality of the IDdevice 30.

As mentioned above, the markers of the access port or other implantedmedical device can include other modalities instead of ultrasound. FIGS.3A and 3B depict one example of this, wherein the access port 12includes a plurality of markers 40 that are configured to react toimpingement thereon of electromagnetic radiation of a predeterminedwavelength. In particular, three markers 40 are positioned on the body14 of the access port in a triangular configuration about the septum 16.Other numbers, sizes, positions, etc., of the markers can also beemployed with this or other types of implantable medical devices. Themarkers 40 can be attached to or integrated with the port body 14 in anynumber of suitable ways, including deposition or adhesion of a markermaterial on the port surface, molding or insertion into a cavity definedin the port, etc. In one embodiment, all or a portion of the access portbody itself can serve as a marker, wherein the body material includesmaterial that enables it to produce a return signal as further describedbelow.

When disposed on an access port or other device that is implanted withinthe patient's body, the markers 40 described above are configured toemit, reflect, or fluoresce a return beam of electromagnetic radiationwhen impinged by an incident, external beam of electromagnetic radiationdirected through the patient's skin and tissue toward the implantedport. For instance, in one embodiment, the markers 40 on the implantedport 12 include a material that emits a return beam of radiation ofinfrared wavelength when impinged upon by an incident beam of infraredelectromagnetic radiation. The emitted infrared radiation from themarkers 40 can be detected external to the patient, thus enablinginformation regarding one or more attributes of the port to beascertained after port implantation.

In another embodiment, other wavelengths of electromagnetic radiationcan form the incident beam, such as radiation in the ultraviolet (“UV”)wavelength, resulting in a return beam of UV radiation from the markers40 and through the patient's tissue for detection outside of thepatient's body. Note that the term “beam” is used herein merely toindicate some amount of radiation travelling in one or more generaldirections. In yet other embodiments, other suitable radiationwavelengths, including visible or radiofrequency (“rF”) wavelengths maybe employed. Also, in one embodiment, the markers can be configured suchthat, when impinged by an incident beam of radiation of a firstwavelength, they emit a return beam of radiation of a second, distinctwavelength, such as IR for the incident beam and UV for the return beam.In this instance, an organic IR-to-UV photo-excitable phosphor withsuitable fluorescence can be employed for the marker. Such a marker mayneed to be encapsulated so as to provide biocompatibility. Moregenerally, other suitable phosphors may be employed in the describedembodiments. In another embodiment, the radiation emitter cansimultaneously or sequentially emit radiation over a spectrum ofwavelengths and the return beam includes one or more of the wavelengthsemitted. In yet another embodiment, the marker can include an LED lightattached to or integrated with the medical device, the LED light beingdetectable by an external detection device when the illuminating. Theseand other such variations are therefore contemplated.

FIGS. 4A and 4B show details of the ID device 30, configured here todetect an implanted port, such as the port 12 including the markers 40as shown in FIGS. 3A and 3B, post-implantation. As shown, the ID device30 in the present embodiment includes a signal source, such as an LED44, for producing and emitting the incident beam of infraredelectromagnetic radiation. The ID device 30 further includes a detector,such as a CCD camera 46, for detecting a return beam of radiationreceived from the markers 40. The LED 44 and camera 46 are disposed on abottom face of the ID device 30 or in another manner to provide forsuitable transmission and reception of the radiation beams. Standoffs 48are included with the ID device 30 in the present embodiment to providefor adequate separation of the LED and camera with respect to thepatient's skin 28 and the implanted port 12. In other embodiments, thestandoffs can be adjustable or omitted from the ID device. In yetanother embodiment, the beam produced by the LED or other signal sourcecan be focused.

As shown in FIG. 4A, during operation the ID device is placed againstthe skin 28 of the patient proximate the location where the port isbelieved to be subcutaneously disposed. In the present embodiment, thestandoffs 48 of the ID device 30 are placed into contact with the skin28, but in other embodiments, the ID device can be merely held over theskin without contacting it. An incident beam of infrared radiation isemitted by the LED 44 and directed for travel through the body tissuefor impingement upon the markers 40 included on the subcutaneous port12. Impingement of the incident beam on the markers 40 causes themarkers to emit a return beam of infrared radiation that is transmittedthrough the body tissue and detected by the camera 46 of the ID device30. As before, the ID device 30 includes suitable circuitry andalgorithms to interpret the return beam and determine the attribute(s)of the port 12 as indicated by the markers 40, such as the powerinjectability of the port, for instance.

In one embodiment, for example, detection by the ID device 30 of thereturn beam of infrared radiation indicates that an implanted deviceincluding markers that produced the return beam is located below thedevice. The ID device 30 can then interpret the received return beamaccording to data programmed, stored, or otherwise received by thedevice as to the attribute represented by the marker of the port thatproduced the return beam. Information relating to the port attribute canthen be depicted on the display 36 of the ID device 30, or otherwiseconveyed to the user of the ID device. FIG. 4A gives one example of animage 36A depicted on the display 36, providing a stored representativeimage of the port and indicating that the port is power injectable. FIG.4B gives another example of the image 36A, wherein depictions of themarkers 40 as detected according to the present position of the IDdevice 30 over the access port 12 are shown together with an indicationof the power injectability of the port. It is therefore appreciated thata wide variety of depictions can be displayed by the system 10 toindicate a wide variety of attributes of the access port or otherimplanted medical device. In one embodiment, it is appreciated that theID device can be used to identify different types of devices, e.g.,access ports vs. catheters, etc.

With respect to the incident beam of electromagnetic radiation, it isappreciated that the wavelength thereof can be tuned by the ID device soas to more readily enable identification of the return beam from theport markers when received by the device and prevent possible confusionby other proximate radiation sources that may be present. Also note thatthe markers can be configured to emit a return beam of wavelengthdifferent than that of the incident beam, as already mentioned. Theseand other such variations are therefore contemplated.

FIGS. 5 and 6 show various details regarding the ID device 30 accordingto one embodiment, wherein a light shield 50 including opposing openends is included for attachment to a bottom portion of the device. Soconfigured, the light shield 50 can act as a shield to preventenvironmental light or other electromagnetic radiation from entering thevolume within the tube, thus enabling the camera 46, disposed within thedark are created by the light shield, to be a low-lux camera. In such anembodiment, the light shield 50 is manufactured as to be substantiallynon-transmissive to electromagnetic radiation that would interfere withthe sensitivity of the camera 46. Such non-transmissiveness can beachieved via a coating applied to the outer or inner shield surface, orby including non-transmissive materials in the material from which thelight shield is formed.

As shown in FIG. 5, in one embodiment a plurality of LEDs 44 can bearranged about a bottom perimeter of the ID device 30 such that beamsemitted from each LED are transferred to the tissue of the patientprimarily along beam paths 52 through the longitudinal length of thelight shield 50 itself when attached to the ID device. The light shield50 can include acrylic or other suitable material, and can be removablyor permanently attached to the ID device 30. Though cylindrical here,the light shield can include one of several possible shapes toaccommodate mating with the ID device and the patient's skin surface.

FIG. 7 shows another embodiment of the ID device 30, wherein a projector54 is included on a bottom face of the device so as to enable arepresentative projection of the detected access port 12 or otherimplanted device to be displayed on the skin 28 of the patient directlyabove the detected location of the port. In particular, detection of theaccess port 12 is made via the use of an incident beam (produced by theLEDs 44 of the ID device 30) impinging on the markers 40 of the port 12and consequent reception of a return beam from the markers 40 asdetected by the camera 46, as in earlier embodiments. This in turnenables an attribute of the port 12, i.e., its location under the skin28, to be determined by the ID device 30, due to the ability of the IDdevice to determine the geometries of the incident beam, the returnbeam, and the projected image path. Once the port location isdetermined, the ID device 30 can project a representative projectedimage 58 of the access port, the markers, etc., on to the skin 28 abovethe implanted port location, via the projector 54. This enables aclinician viewing the projected image 58 to ascertain the location ofthe access port 12 and to conveniently access the septum 16 thereof(FIG. 1) with a needle or other device. Such projection can be employedin addition to or instead of depiction of information on a display ofthe ID device. The projected image 58 can include one or more of variousdesigns, words, images, etc., including a depiction of the markersactually detected by the camera 46 or an image stored in a memorylocation of the ID device 30 corresponding to the type of access portidentified by the ID device according to the markers detected thereby.

FIG. 8 shows another embodiment of the ID device 30, wherein the IDdevice 30 is not a self-contained unit, but rather includes separatecomponents. In detail, the ID device 30 includes a handheld module 30Acontaining a needle guide 60 for holding a needle 62, an outlet foremitting a beam of electromagnetic radiation, a camera for detectingreturn signals from the markers, and the projector 54 for projecting theimage 58 of the port 12, once detected.

The ID device 30 further includes a component module 30B operablyconnected to the handheld module 30A via a cable 30C. The componentmodule 30B in the present embodiment includes a lighting system fortransmitting electromagnetic radiation from the component module to theoutlet on the handheld module via a suitable conduit in the able 30C,and necessary circuitry and electronic modules to enable ID devicefunctionality. Such an ID device design provides a relatively smallhandheld device for use in locating and identifying the implanteddevice, thus providing enhanced convenience for the user.

FIGS. 9A and 9B show that a representative image of the implanted accessport 12 can assist in determining orientation of the portpost-implantation. As shown in FIG. 9A, when the port 12 is positionedwithin the body so as to be substantially parallel to the skin, themarkers 40 thereof will be detected by the ID device with a desiredorientation, or spacing, with respect to one another. The ID deviceprojector 54 can then project the representative image 58 of the markers40 with the same orientation, thus indicating to the observer that theport is properly positioned.

If the port has rotated to an oblique orientation within the body, asseen in FIG. 9B, the ID device 30 will detect the port markers 40 with adifferent spacing and will display the projected image 58 as such, thusindicating the port orientation is oblique. A similar situation could beobserved on the image 36A of the device display 36, if desired (FIGS.4A, 4B).

FIGS. 10A-10C show examples of other possible configurations forplacement of the markers 40 on the access port 12, including placementof marker dots on the port septum 16, stripes across the septum, and astripe about the septum perimeter. These and other marker configurationsare therefore possible, as appreciated by one skilled in the art. Notealso that these marker configurations are representative for placementon other implantable devices as well.

FIG. 11 shows that in one embodiment the marker can include an active orpassive RFID chip 70, detectable by an RFID reader component included inthe ID device 30. So configured, ample information regarding attributesof the access port 12 or other implanted device can be determined upondetection of the RFID chip 70 by the reader of the ID device.

FIGS. 12A and 12B depict details regarding a needle guide assembly 80for use with the ID device 30, according to one embodiment. The needleguide assembly 80 includes a body 82 configured to snap-on or otherwiseattach to a portion of the ID device 30, such as the standoffs 48 (FIG.12B), when used with an ID device similar to that shown in FIG. 4A. Thebody 82 includes a needle guide 84 for guiding a needle 86. A dressing88 is rolled up in an undeployed configuration and attached to a portionof the body 82. The needle 86 pierces both the body 82 and the dressing88. So configured, the needle guide assembly 80 is useful to guide theneedle 86 into the septum of an implanted access port while using the IDdevice 30 to locate the port, such as via the projected image 58 of theport, as shown in FIG. 12B. After the needle has been placed, thedressing 88 can be removed from the body 82, then unrolled and deployedon the skin over the insertion site of the needle 86 to provide abarrier and dressing for the insertion site, as shown in FIG. 12C. Inone embodiment, the dressing includes antimicrobial properties.

FIG. 13 shows a needle guide assembly 90 according to anotherembodiment, including a body 92 shaped for grasping by a user and a slotdefined by the body for receiving therethrough a needle 96. A needleguide can be included in the slot to assist with guiding the needle 96.An undeployed, rolled up dressing 98 (shown partially unrolled in FIG.13) is also included, the dressing being pre-punctured by the needle 96.The needle guide assembly 90 is employed to enable the needle 96 to beinserted into an insertion site of the patient, then to cover the skinproximate insertion site with the dressing 98 without first removing theneedle from the patient.

Embodiments of the invention may be embodied in other specific formswithout departing from the spirit of the present disclosure. Thedescribed embodiments are to be considered in all respects only asillustrative, not restrictive. The scope of the embodiments is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. An identification system, comprising: an accessport; a catheter coupled to the access port, the catheter including aplurality of markers positioned along a longitudinal length of thecatheter, wherein the plurality of markers are: (i) arranged in abarcode format designed to provide information relating to an attributeof the access port; and (ii) detectable via ultrasound when the catheterand the access port are subcutaneously implanted in a patient; and aself-contained handheld external detection device, including: anultrasound transducer designed to produce an ultrasound signal forimpingement on the plurality of markers and to detect an ultrasoundsignal reflection by the plurality of markers; and a display designed todepict information derived from the ultrasound signal reflectionregarding the attribute of the access port.
 2. The identification systemaccording to claim 1, wherein the plurality of markers arranged in thebarcode format are non-uniformly spaced.
 3. The identification systemaccording to claim 1, wherein the access port comprises a set of portmarkers arranged in a predetermined spaced apart relationship, andwherein the ultrasound transducer is designed to produce an ultrasoundsignal for impingement on the set of port markers and to detect anultrasound signal reflection by the set of port markers.
 4. Theidentification system according to claim 3, wherein the set of portmarkers includes a body port marker positioned on a body of the accessport.
 5. The identification system according to claim 4, wherein thebody port marker is designed to indicate an implanted location of theaccess port.
 6. The identification system according to claim 3, whereinthe set of port markers are designed to assist in determining anorientation of the access port.
 7. The identification system accordingto claim 3, wherein the set of port markers includes a septum markerassociated with a septum of the access port.
 8. The identificationsystem according to claim 3, wherein the display projects arepresentative image of the relative spacing of the set of port markersto indicate to an observer that the access port is properly positioned.9. The identification system according to claim 8, wherein the detectiondevice compares the relative spacing of the set of port markers todetermine whether an orientation of the access port is substantiallyparallel to a skin surface of the patient or whether the orientation ofthe access port is oblique to the skin surface of the patient.
 10. Theidentification system according to claim 1, wherein the attribute of theaccess port includes structure to withstand power injection of a fluid.